Lupin Limited said that it has been issued the establishment inspection report (EIR) from the US Food and Drug Administration (US FDA) for its manufacturing facility in Goa following an inspection in September 2021. The US FDA determined that the inspection classification of the Goa manufacturing facility is voluntary action indicated (VAI). Voluntary Action Indicated […]
Lupin Limited has launched its diagnostics business in India under the name Lupin Diagnostics as part of its efforts to offer integrated healthcare in India. Lupin Diagnostics, which is a fully-owned subsidiary of Lupin has formally begun operations. It has set up a 45,000 sft national reference laboratory in Navi Mumbai. With high-quality equipment, experienced […]
Lupin Limited has signed an exclusive distribution and marketing agreement with Biomm SA for biosimilar Pegfilgrastim in Brazil. The Indian pharma company had earlier secured the US Food and Drugs Administration (FDA) acceptance of the biologics license application (BLA) for its proposed biosimilar to Neulasta (pegfilgrastim) via a filing using the 3Sl(k) pathway. Pegfilgrastim is […]
Lupin Limited has launched the generic version of Antara (Fenofibrate) Capsules, 30 mg and 90 mg, of its fully-owned Lupin Atlantis Holdings in the US. According to the Indian pharma company, Fenofibrate Capsules are approved to be used as an adjunctive therapy to diet to decrease elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (total-c), Triglycerides […]
Lupin said that the UK’ National Institute for Health and Care Excellence (NICE) has recommended Namuscla (mexiletine), an antimyotonic agent, for the approval of its use in the treatment of symptomatic myotonia in adults with non-dystrophic myotonic disorders (NDM). The Indian pharma company, through its subsidiary — Lupin Healthcare (UK), has agreed to a confidential […]
Lupinlife, the consumer healthcare business of Lupin Limited, has roped in Bollywood actor Hrithik Roshan as the brand ambassador for its recently launched Be One ayurvedic energy supplement. Hrithik Roshan said: “I’m happy to partner with Lupinlife’s Be One, an Ayurvedic, non-addictive daily health supplement. This meets the modern day needs of energizing the mind […]
Lupin Limited said that it has rolled out the authorized generic version of Horizon Medicines’ Duexise (ibuprofen and famotidine) Tablets, 800 mg/26.6 mg. Ibuprofen and Famotidine Tablets, 800 mg/26.6 mg, are used for alleviating signs and symptoms of rheumatoid arthritis and osteoarthritis. The drug is also used for lowering the risk of developing upper gastrointestinal […]
Indian pharma company Lupin Limited has secured a non-exclusive license from TB Alliance, a non-profit drug developer, for manufacturing the anti-TB drug pretomanid. Pretomanid is part of the three-drug BPaL regimen (made up of bedaquiline, pretomanid, and linezolid), intended for the treatment of highly drug-resistant tuberculosis (TB). Mel Spigelman — President and CEO of TB […]
Lupin Limited said that it has been granted tentative approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Brivaracetam Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg. Brivaracetam Tablets is a generic equivalent of Briviact Tablets, 10 mg, 25 mg, 50 mg, 75 […]
Indian pharma company Lupin Limited has launched Tavaborole Topical Solution, 5% following regulatory approval from the US Food and Drug Administration (FDA). Tavaborole Topical Solution, 5%, is a generic version of Kerydin Topical Solution, 5%, owned by Anacor Pharmaceuticals. It is an oxaborole antifungal, which has been approved by the FDA for the topical treatment […]